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Triethanolamine; Exemption from the Requirement of a Tolerance

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Information about this document as published in the Federal Register.

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AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes an exemption from the requirement of a tolerance for residues of triethanolamine (CAS Reg. No. 102-71-6) when used as an inert ingredient in pesticide formulations applied to growing crops under 40 CFR 180.920. Bayer CropScience, LP submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an expansion of the existing § 180.920 exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of triethanolamine.

DATES:

This regulation is effective March 25, 2009. Objections and requests for hearings must be received on or before May 26, 2009, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:

EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2008-0346. All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.

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FOR FURTHER INFORMATION CONTACT:

Keri Grinstead, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8373; e-mail address: grinstead.keri@epa.gov.

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SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

  • Crop production (NAICS code 111).
  • Animal production (NAICS code 112).
  • Food manufacturing (NAICS code 311).
  • Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

In addition to accessing electronically available documents at http://www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr. You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/​ecfr.

C. Can I File an Objection or Hearing Request?

Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2008-0346 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before May 26, 2009.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2008-0346, by one of the following methods:

  • Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
  • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
  • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Start Printed Page 12618Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

In the Federal Register of June 4, 2008 (73 FR 31862) (FRL-8365-3), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 8E7332) by Bayer CropScience LP, P.O. Box 12014, 2 T.W. Alexander Dr., Research Triangle Park, NC 27709. The petition requested that the exemption in 40 CFR 180.920 for triethanolamine be amended by removing the restriction that triethanolamine could only be used in formulations applied before the crop emerged from the soil. That notice included a summary of the petition prepared by the petitioner. There were no comments received in response to the notice of filing.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

III. Inert Ingredient Definition

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene ploymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

IV. Toxicological Profile

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by triethanolamine are discussed in this unit.

Triethanolamine has an existing exemption from tolerance under 40 CFR 180.920 when used as an inert ingredient in pesticide formulations applied before the crop emerges from the soil. This exemption was reassessed by EPA in 2006 and the reassessment document can be found at http://www.epa.gov/​opprd001/​inerts/​decisiondoc_​a2k.html. For ease of reading, triethanolamine is referred to as TEA. Summaries of the assessment for TEA are presented in this final rule. For more detailed information, refer to the docket for the more comprehensive assessment/decision document.

In animal studies, TEA has low acute toxicity via the oral and dermal routes, was nonirritating in eye and skin irritation studies, and did not induce skin sensitization. In repeat-dose testing, the main effect was on the liver and kidney with adverse effects seen at oral doses > 170 milligrams/kilogram/day (mg/kg/day). TEA is unlikely to be carcinogenic and studies indicate it is not mutagenic or developmentally toxic. Reproductive parameters were not affected in rats and mice treated dermally with TEA. When ingested, TEA appears to be rapidly absorbed in the gastrointestinal tract. In rodent studies, TEA was eliminated largely unchanged in the urine and feces within 2 days.

V. Aggregate Exposures

In examining aggregate exposure, section 408 of FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

The primary route of exposure to TEA from its use as an inert ingredient in pesticide products applied to growing crops would most likely be through consumption of food to which pesticide products containing TEA have been applied, and possibly through drinking water (from runoff). Residential (dermal and inhalation) exposures are also possible from the use of home garden pesticide products containing TEA as an inert ingredient.

There are no data provided regarding TEA residues in food or any other nonoccupational exposures to TEA. In the absence of actual residue data for TEA, the Agency performed a dietary (food and drinking water) exposure assessment for TEA when used as an inert ingredient in pesticide formulations applied to growing crops by using a series of very conservative assumptions. This exposure assessment was calculated based on the following Start Printed Page 12619assumptions: (1) TEA would be used as an inert ingredient in all food use pesticide formulations applied to all crops, (2) 100% of all food crops would be treated with pesticide products containing TEA, (3) TEA residues would be present in all crops at levels equal to or exceeding the highest established tolerance levels for any pesticide active ingredient, and (4) TEA would be present in all sources of drinking water at concentrations equal to the highest established standards for drinking water contaminants established by EPA. This approach is highly conservative as it is extremely unlikely that TEA would have such use as a pesticide product inert ingredient and be present in food commodities and drinking water at such high levels. In addition, this highly conservative exposure assessment is protective of any possible non-occupational exposures to TEA, as it results in exposure estimates which are orders of magnitude greater than the high-end exposure estimates for residential uses of pesticides routinely used by EPA's Office of Pesticide Programs.

VI. Cumulative Effects

Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to TEA and any other substances and, TEA does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that TEA has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/​pesticides/​cumulative/​.

VII. Safety Factor for the Protection of Infants and Children

Section 408(b)(2)(c) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

1. The database is considered adequate for FQPA assessment based on available subchronic (rats), chronic/carcinogenicity (rats and mice), developmental (rats and mice), and reproduction (rats and mice) toxicity studies. No acute or subchronic neurotoxicity studies are available, but there were no clinical signs of neurotoxicity observed in the available database. Therefore, the Agency concluded that these studies are not required. In addition, the developmental neurotoxicity study is not required because there is no evidence of increased susceptibility to infants and children in the available developmental and reproduction studies in rats and mice and no clinical signs of neurotoxicity in the available studies. Based on the overall evidence, the Agency concluded that the database for triethanolamine is adequate for FQPA.

2. Based on the developmental toxicity studies, EPA concludes that there is no evidence of increased susceptibility to infants and children. Developmental toxicity study in rats via the dermal route resulted in no biologically significant effects in the offspring or in the maternal animals. An oral Chernoff-Kavlock screening test resulted in a no observed adverse effect level (NOAEL) of 1,125 mg/kg/day in mice and it was determined that oral administration of the test material did not affect maternal mortality, the number of viable litters, length of gestation, litter size, percent survival of the pups or birth weight or weight gained by the pups. No quantitative or qualitative evidence of susceptibility was observed from any of the currently available toxicological data.

3. No reproductive parameters were affected in rat and mice treated dermally at doses up to 2,000 and 4,000 mg/kg/day, respectively.

4. No evidence of treatment related clinical signs of neurotoxicity was observed in the available toxicological studies. EPA concluded that the developmental neurotoxicity study is not required.

5. The highly conservative dietary exposure assessment using default assumptions would not underestimate the risk to infants and children.

VIII. Determination of Safety for U.S. Population

For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic dietary risks by comparing aggregate food and water exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the POD by all applicable UFs.

Residues of concern are not anticipated for dietary exposure (food and drinking water) or for residential exposure (inhalation and dermal) from the use of TEA as an inert ingredient in pesticide products. The toxicology data indicate that TEA does not pose an acute risk. Chronic risk was assessed by comparing aggregate exposure to TEA to a cPAD of 1.70 mg/kg/day (based on the subchronic oral rat study with a NOAEL of 170 mg/kg/day and a safety/uncertainty factor of 100X). Utilizing the highly conservative aggregate exposure assessment described above, the resulting chronic exposure estimates do not exceed the Agency's level of concern (children 1-2 years were the most highly exposed population with the chronic exposure estimates occupying 26.6% of the cPAD). In addition, this highly conservative exposure assessment is protective of any possible non-occupational exposures to TEA, as it results in exposure estimates orders of magnitude greater than the high-end exposure estimates for residential uses of pesticides routinely used by EPA's Office of Pesticide Programs. Start Printed Page 12620

Taking into consideration all available information on TEA, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to TEA residues. Therefore, the establishment of an exemption from the requirement of a tolerance under 40 CFR 180.920 for residues of TEA when used as an inert ingredient in pesticide formulations applied to growing crops, is safe under section 408(q) of the FFDCA.

IX. Other Considerations

A. Analytical Method

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

B. Existing Exemptions

Triethanolamine has an existing exemption from the requirement of a tolerance under 40 CFR 180.920 for use as an inert ingredient in pesticide formulations applied before the crop emerges from the soil.

C. International Tolerances

The Agency is not aware of any country requiring a tolerance for triethanoloamine nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time.

X. Conclusions

Therefore, an exemption from the requirement for a tolerance is established for triethanolamine when used as an inert ingredient in pesticide formulations applied to growing crops.

XI. Statutory and Executive Order Reviews

This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

XII. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

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List of Subjects in 40 CFR Part 180

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Dated: March 3, 2009.

Lois Rossi,

Director, Registration Division, Office of Pesticide Programs.

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Therefore, 40 CFR chapter I is amended as follows:

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PART 180—[AMENDED]

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1. The authority citation for part 180 continues to read as follows:

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Authority: 21 U.S.C. 321(q), 346a and 371.

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2. In § 180.920, the table is amended by revising the entry for “Triethanolamine” to read as follows:

End Amendment Part
Inert ingredients used pre-harvest; exemptions from the requirement of a tolerance.
* * * * *
Inert ingredientsLimitsUses
*   *   *    *   *
Triethanolamine (CAS Reg. No. 102-71-6)Stabilizer, inhibitor
*   *   *    *   *
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[FR Doc. E9-6263 Filed 3-24-09; 8:45 am]

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